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Keytruda therapeutic expansions and approvals

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2026-10-23 11:43 UTC → 2026-10-23 23:21 UTC · added ~~removed~~

The immunotherapy drug Keytruda has seen recent developments regarding new formulations and expanded clinical applications. In South Korea, MSD Korea announced the October launch of a subcutaneous (SC) formulation of Keytruda. Utilizing Alteogen’s ‘berahyaluronidase alfa’, this version aims to significantly reduce administration time from approximately 30 minutes for intravenous doses to between 1 and 2 minutes. Clinical studies indicated that the SC formulation is non-inferior in drug exposure to the intravenous version and was preferred by 65% of patients in a crossover study due to increased comfort and shorter hospital stays. In the European Union, the European Commission has approved a combination of Keytruda and Padcev for the perioperative treatment of adults with resectable muscle-invasive bladder cancer (MIBC). This regimen can be used as neoadjuvant therapy before radical cystectomy or as adjuvant treatment following surgery. The authorization covers all 27 EU member states, as well as Iceland, Liechtenstein, and Norway. The approval follows the Phase III ~~KEYNOTE-B15~~ KEYNOTE-B15/EV-304 study, which showed the combination reduced the risk of disease recurrence, progression, or death by 47% compared to standard chemotherapy and surgery. This regulatory decision provides a treatment option for patients regardless of their eligibility for cisplatin-based chemotherapy, a group that includes approximately 50% of patients.

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